Regulatory and Compliance Support (FDA, HIPAA, IEC)

The contract requires comprehensive regulatory documentation and compliance support for medical device standards including FDA 501(k) premarket submissions, HIPAA privacy and security requirements, ADA accessibility guidelines, and IEC 60601-2 safety standards for medical electrical equipment. The scope includes preparing all necessary submissions for FDA clearance, ensuring ongoing compliance with federal regulations, and maintaining audit readiness across all applicable domains to support the procurement of medical devices by the Department of Veterans Affairs. The work must align with current regulatory expectations and be executed to ensure seamless regulatory pathway management from documentation through to approval and beyond. This is a subcontract under a Service-Disabled Veteran-Owned Small Business Set Aside, identified by NAICS code 541620, which classifies it under other scientific and technical consulting services. The solicitation was posted on July 1, 2026, with a response deadline of July 29, 2026, and is managed by the Sac Frederick contracting office within the Department of Veterans Affairs. While specific performance location details are not provided, the successful offeror must be capable of delivering full regulatory compliance services remotely or on-site as needed to support the agency’s medical technology acquisition goals. The contractor must demonstrate proven experience in navigating complex regulatory frameworks and possess the technical expertise to handle end-to-end compliance lifecycle management for federally regulated healthcare devices.